Adjusting Europe's drug regulation to public health needs

Abstract

The inauguration of the European Medicines Evaluation Agency (EMEA) 5 years ago, revolutionised the European pharmaceutical system. The new system saves member states of the European Union time and effort in assessing marketing authorisation applications, and ensures a homogeneous regulatory policy throughout the European Union. Pharmaceutical companies apply only once for marketing authorisations, extensions, and variations; thus they avoid the uncertainty caused in the past by different procedures and bureaucracies in the 15 member states. However, harmonisation is far from complete because prices and reimbursability of products are left to individual member states, which have different health systems. CPMP (Committee for Proprietary Medicinal Products), the scientific advisory committee, and EMEA’s technical and administrative staff have made the new system efficient and reliable: 126 products (98 active ingredients) have been positively assessed and released for marketing by the European Commission. EMEA’s merits are undisputed and its effect on the pharmaceutical area rightly acknowledged. However, some aspects of the system need to be reviewed to ensure that patients derive maximum advantage. Institutional location of EMEA EMEA is located in an industrial institution of the European Commission (initially called Directorate General [DG] III, now called DG Enterprise) despite the fact that its mission is “to promote the protection of human health . . . and of consumers of medicinal products”. 1 Public health should be the fundamental concern of EMEA because it is the final outcome of improved availability of medicines. The pharmaceutical industry aims to enlarge its market to maximise profits. Consumers, who are frequently anxious to have access to drugs even while they are still in an early stage of assessment, can be biased in assessing the merit of therapies. If public health issues were paramount, EMEA approval of new drugs would depend on their benefit to patients, and would be granted only for well defined indications after extensive research. Removal of EMEA from its industrial location would therefore indicate political willingness to think of patients as more important than the interests attached to the production of medicines.